Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent ...
FDA Drug Recall #D-1862-2019 — Class II — September 6, 2019
Recall Summary
| Recall Number | D-1862-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 6, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Torrent Pharma Inc. |
| Location | Basking Ridge, NJ |
| Product Type | Drugs |
| Quantity | 2472 bottles |
Product Description
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Lot / Code Information
Lot #: BFE2E003, Exp 08/31/2020
Other Recalls from Torrent Pharma Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0455-2025 | Class II | Fluoxetine Tablets, USP, 20 mg, 30-count bottl... | May 27, 2025 |
| D-0456-2025 | Class II | Fluoxetine Tablets, USP, 20 mg, 28-count Carton... | May 27, 2025 |
| D-0365-2022 | Class II | Carbamazepine Tablets, USP 200 mg 100 Tablets R... | Dec 2, 2021 |
| D-0285-2022 | Class III | Telmisartan and Hydrochlorothiazide Tablets, US... | Dec 1, 2021 |
| D-1317-2020 | Class II | Carbamazepine Tablets, USP 200 mg, packaged in ... | May 11, 2020 |
Frequently Asked Questions
Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.